a phase 2 study of plx3397 in patients with recurrent glioblastoma

Conditions: Recurrent Glioblastoma

Summary: the objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of plx3397.


Eligibility criteria:
inclusion criteria: * male or female patients ≥18 years old with a life expectancy of at least 8 weeks * radiographically proven recurrent (≥ first relapse), intracranial glioblastoma (gbm) * for all patients, availability of at least 10 unstained slides (or archival tumor block sufficient to generate at least 10 unstained slides) from any previous gbm surgery * previous treatment with external beam radiation and temozolomide chemotherapy * before the first dose of plx3397,adequate recovery from toxicity of prior therapy as follows: \>28 days for cytotoxic therapy \>42 days for nitrosoureas \>28 days for bevacizumab \>7 days for non cytotoxic therapy such as interferon, tamoxifen, thalidomide, cis-retinoic acid, or erlotinib * women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug. * karnofsky performance status of ≥60 * adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/l, hgb \>9 g/dl, platelet count ≥50 x 109/l, aspartate aminotransferase/alanine aminotransferase (ast/alt) ≤2.5x upper limit of normal (uln), creatinine ≤1.5x uln) * willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements exclusion criteria: * investigational drug use within 28 days of the first dose of plx3397 * gbm progression within 3 months of previous radiation by response assessment in neuro-oncology (rano) criteria * history of grade 2 common toxicity criteria for adverse events (ctcae v4) or greater acute intracranial hemorrhage * previous failure of bevacizumab or other vascular endothelial growth factor (vegf) therapy except in a first line setting * history of malignant glioma with co-deletion of 1p/19q * a concurrent active cancer that requires non-surgical therapy (e.g. chemotherapy, radiation, adjuvant therapy). prior history of other cancer is allowed, as long as there was no active disease within the prior 3 years. * refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption * patients with serious illnesses, uncontrolled infection, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results * women of child-bearing potential who are pregnant or breast feeding * corrected qt interval (qtc) ≥450 msec at screening

Keywords: glioblastoma brain cancer